1. Field of the Invention
The present invention relates generally to methods and apparatus for sequentially accessing the uterus and fallopian tubes of a patient. More particularly, the present invention relates to a method and catheter system for performing hysterosalpingography followed by optionally accessing the fallopian tubes.
Diseases of the fallopian tubes are a major cause of infertility and tubal pregnancy. Until recently, diagnosis and treatment of tubal disease has been hampered by the difficulty in accessing and imaging the interior of the fallopian tubes in a least invasive manner. Such difficulties, however, have been largely overcome by the present availability of very small guidewires, catheters and fiberoptic viewing scopes, usually referred to as falloposcopes. Particular systems and methods employing a hysteroscope in combination with the guidewire and small diameter fallopian access catheter for accessing and viewing the interior of the fallopian tubes are described in Kerin et al. (1990) Fertil. Steril. 54:390-400 and J. Laparo. Endoscopic Surg. 1:47-56, and copending patent application Ser. No. 08/207,475, assigned to the assignee of the present application.
A common medical procedure for imaging the uterus and fallopian tubes is referred to as hysterosalpingography. Such procedures rely on injecting contrast media into the uterus and fallopian tubes using a uterine access catheter having an elastomeric balloon near its distal end for sealing against the cervix. The anatomical structures of the uterus and fallopian tubes are then fluoroscopically imaged in a conventional manner. In some cases, however, contrast media injected into the uterus does not fully pass into the fallopian tubes. If the fallopian tubes are not filled with the contrast media, subsequent imaging may be inadequate.
In such circumstances, it has been proposed to pass a pair of coaxial catheters through the uterine access catheter in order to access the fallopian tubes. In particular, an outer catheter is used to engage the fallopian os and a smaller tubular catheter is passed through the outer catheter and into the fallopian tube. Contrast media can then be injected directly into the fallopian tube for improved imaging. Such systems are described in U.S. Pat. No. 5,372,584.
While such coaxial catheter systems for selectively accessing the uterus and fallopian tubes are generally successful, they rely on using a relatively large diameter uterine access catheter. In particular, the uterine access catheter must be sufficiently large to pass the coaxial catheter system which is used to enter the fallopian tubes. The need to pass a larger catheter through the cervix significantly increases patient discomfort and can be more difficult for the physician to insert. While it would be possible to initially employ a small catheter for contrast media introduction, subsequent fallopian tube access would then require use of a second, larger uterine access catheter, thus increasing the cost and complexity of the procedure.
For these reasons, it would be desirable to provide improved methods and apparatus for performing hysterosalpingography. Such methods and apparatus will preferably provide for initial introduction of contrast media using a small diameter uterine access catheter followed by optionally accessing the fallopian tubes using a separate catheter system without the need to introduce a separate uterine access catheter. Such methods and apparatus should reduce the complexity and cost of performing hysterosalpingography and related fallopian tube access procedures. It would be further desirable if such apparatus were useful for other gynecological procedures, such as treatment of proximal tubal occlusion, endoscopic tubal examination, transcervical gamete intrafallopian transfer (GIFT), therapeutic drug delivery for treatment of ectopic pregnancies, endometrial biopsy, intrauterine ultrasound, removal of myomas, polyps, and/or septums, and the like.
2. Description of the Background Art
U.S. Pat. No. 5,372,584, describes a catheter system for performing hysterosalpingography and selective salpingography. Catheter systems and methods for accessing the fallopian tubes are described in U.S. Pat. Nos. 5,389,089; 5,379,247; 5,300,023; and 5,147,315. Catheters intended for uterine access and/or manipulation are described in U.S. Pat. Nos. 5,259,836; 5,104,377, 4,496,345; 4,430,076; and WO 96/22122. Other catheter systems are described in U.S. Pat. Nos. 5,273,526 and 5,211,627. A cervical cannula is described in SU 730355. Laparoscopic cannulas comprising coaxial tubular members are described in U.S. Pat. Nos. 5,002,557 or 5,176,697. A cervical manipulator comprising an inner balloon member and outer cervical cap is described in U.S. Pat. No. 5,209,754. Devices manufactured under U.S. Pat. No. 4,430,076, are sold by BEI Medical Systems under the trade names ZUMI and AUI, as described in a catalogue of BEI.
A coaxial catheter system for accessing and imaging a fallopian tube is described in copending application Ser. No. 08/207,475, filed on Mar. 7, 1994, assigned to the assignee of the present application, the full disclosure of which is incorporated herein by reference.